Gabapentin for Carpal Tunnel Syndrome - Full Text View

Sponsor:	Chinese University of Hong Kong
Collaborator:	Pfizer
Information provided by:	Chinese University of Hong Kong
ClinicalTrials.gov Identifier:	NCT00137735

Purpose

The purpose of this study is to determine whether gabapentin is safe and effective in the treatment of carpal tunnel syndrome (CTS).

Condition	Intervention	Phase
Carpal Tunnel Syndrome	Drug: Gabapentin Other: placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Gabapentin for Carpal Tunnel Syndrome: A Randomised Controlled Trial

Resource links provided by NLM:

Genetics Home Reference related topics: Charcot-Marie-Tooth disease hereditary neuropathy with liability to pressure palsies

MedlinePlus related topics: Carpal Tunnel Syndrome

Drug Information available for: Gabapentin Gabapentin enacarbil

U.S. FDA Resources

Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:

Global symptom score (GSS) recorded by a physician blinded to the allocation of treatment at 8 weeks [ Time Frame: 8 weeks ]

Secondary Outcome Measures:

GSS at 2 weeks [ Time Frame: 2 weeks ]
Grip strength as functional assessment at 2 and 8 weeks [ Time Frame: 2 weeks, 8 weeks ]
Tolerability [ Time Frame: throughout subject's participation in trial ]

Enrollment:	150
Study Start Date:	October 2003
Study Completion Date:	December 2006

Arms	Assigned Interventions
Active Comparator: 1 Gabapentin	Drug: Gabapentin 300mg tds
Placebo Comparator: 2 Placebo	Other: placebo tds

Detailed Description:

A variety of treatment options exist at present for carpal tunnel syndrome (CTS) with no universal agreement. Recent reports suggested that untreated CTS might improve or remain stationary. In this respect, treatment directing towards symptom suppression alone may have a role in the initial management of CTS. Gabapentin (1-[aminomethyl]-cyclohexaneacetic acid; Neurontin, Pfizer) is an effective drug for treatment of neuropathic pain and has been reported to be effective in case series for the treatment of CTS with relatively benign side effects profile. The purpose of this study was to evaluate the safety and efficacy of gabapentin in the treatment of CTS.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Sensory symptoms over median nerve distribution for more than three months.
Confirmatory electrophysiologic results defined as prolonged median nerve distal motor latencies (DML) > 4 ms or median-ulnar palmer sensory latency differences > 0.5 ms.

Exclusion Criteria:

Patients with evidence of severe CTS: fibrillation potentials or reinnervation on needle examination of the abductor pollicis brevis muscle or clinical examination showing wastage of the thenar muscles. (These patients were referred for surgical decompression on presentation.)
Clinical or electrophysiological evidence of accompanying conditions that could mimic CTS or interfere with its evaluation, such as proximal median neuropathy, cervical radiculopathy, or significant polyneuropathy.
Known epilepsy.
Patients who have received previous steroid injection or oral steroid therapy for CTS.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00137735

Locations

Hong Kong
Prince of Wales Hospital
Shatin, New Territories, Hong Kong
North District Hospital
Sheung Shui, New Territories, Hong Kong

Sponsors and Collaborators

Chinese University of Hong Kong

Pfizer

Investigators

Principal Investigator:

Andrew CF Hui, FHKAM

Department of Medicine & Therapeutics, Faculty of Medicine, The Chinese University of Hong Kong

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00137735 History of Changes
Other Study ID Numbers:	IG-HK-GAB-01-02
Study First Received:	August 29, 2005
Last Updated:	October 30, 2007
Health Authority:	Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Keywords provided by Chinese University of Hong Kong:

carpal tunnel syndrome
gabapentin

Additional relevant MeSH terms:

Carpal Tunnel Syndrome
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries
Gabapentin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists

ClinicalTrials.gov processed this record on February 09, 2012